MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPEC EF PRIM HO 12/14 SZ 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	71312112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our reference number: (b)(4).
Event or Problem Description
It was reported that, after a thr that had been performed on 2003, there was a revision surgery to address an unspecified event.The spec ef prim ho 12/14 sz 2 was explanted.The current status of patient¿s health is unknown.
Additional Manufacturer Narrative
The affected complaint device, used in treatment, was not returned for evaluation.Therefore, a product analysis could not be performed.There is no information that would suggest the device failed to meet specifications.A review of complaint history revealed prior complaints for the listed part.A relationship, if any, between the device and the reported incident could not be corroborated.According to clinical medical investigation, this case reports the patient underwent a thr revision due to an unspecified reason.To date, the requested surgical records and x-rays have not been provided.Therefore, the patient impact beyond the revision cannot be determined.Due to the lack of information provided, a clinical assessment cannot be rendered at this time.Should additional clinically relevant documentation become available, the clinical/medical task may be re-opened.Based on this investigation, the need for corrective action is not indicated.A review of risk management files and the instructions for use found that the probable cause failures were documented appropriately.The potential probable causes for this event could include but not limited to a patient condition, user or procedural error.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SPEC EF PRIM HO 12/14 SZ 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11373517
• Report Number: 1020279-2021-01557
• Device Sequence Number: 19771625
• Product Code: JDI
• UDI-Device Identifier: 03596010195579
• UDI-Public: 03596010195579
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71312112
• Device Catalogue Number: 71312112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention